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Tarlatamab

Imdylltra · ATC code L01FX33

Key facts
Active substance
Tarlatamab
ATC code
L01FX33
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IMDYLLTRA 1 mg powder for concentrate and solution for solution for infusion / IMDYLLTRA 10 mg powder for concentrate and solution for solution for infusion
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-27

Key facts

Tarlatamab is a bispecific T-cell engager antibody (Imdylltra, infusion). It is used as monotherapy in adults with extensive-stage small cell lung cancer after platinum-based chemotherapy.

What it is used for

  • Extensive-stage small cell lung cancer (ES-SCLC) in adults with progression on or after first-line platinum-based chemotherapy

Dosing

  • Day 1: 1 mg; days 8 and 15: 10 mg; then 10 mg every 2 weeks until progression or unacceptable toxicity
  • Days 1 and 8: dexamethasone 8 mg IV within 1 hour before the infusion, then 1 litre of sodium chloride solution
  • Monitoring for 6 to 8 hours from the start of infusion on days 1 and 8; then 24 hours near a healthcare facility with a caregiver
  • After a dose delay, restart as tabulated in the full text (possibly again at 1 mg)
  • No dose recommendation in moderate/severe hepatic impairment or severe renal impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Cytokine release syndrome (CRS), including life-threatening or fatal events; administer only in facilities equipped to manage it
  • Immune effector cell-associated neurotoxicity syndrome (ICANS), possibly weeks after administration
  • Serious infections, including life-threatening and fatal infections
  • Neutropenia; treatment interruption depending on severity

Side effects

  • Most common: CRS (56.7%), decreased appetite (36.4%), pyrexia (31.9%), dysgeusia (31.3%), constipation (30.4%), anaemia (30.0%), fatigue (29.8%)
  • Also: nausea, asthenia, neutropenia, hyponatraemia, headache, lymphopenia
  • Most common serious: CRS (19.7%) and pyrexia (4.7%)

Interactions

  • No interaction studies; cytokine release at treatment start may suppress CYP450 enzymes
  • Monitor CYP450 substrates with a narrow therapeutic index and adjust their dose as needed

Pregnancy and breastfeeding

  • Pregnancy: may cause foetal harm; not recommended; effective contraception during and for 2 months after treatment
  • Breast-feeding: discontinue during treatment and for at least 2 months after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ImdylltraAmgen Europe B.V. · EMEA/H/C/006451

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Imdylltra
Norway
Imdylltra

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Imdylltra – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/imdylltra-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.